METRONIDAZOLE for Pouchitis

Inclusion criteria

• {"criterion_text":"- Of any gender\n- Over 18 years of age\n- Have a previous diagnosis of ulcerative colitis\n- Have had IPAA surgery, and\n- Have been diagnosed with pouchitis\n- Be able to understand and complete study procedures as determined by the investigator\n- Be able to speak either Danish or English\n- Be able to comply with study procedures for the length of the study\n- Use a highly effective contraception method for the duration of the trial (until day 30 in Phase I and until day 37 in Phase II), such as implants, injectables, oral contraceptives, IUD (intrauterine device), sexual abstinence or vasectomized partner."}

Exclusion criteria

• {"criterion_text":"- Patients with a previous allergic reaction to GM-CSF, metronidazole or fosfomycin\n- Patients who are currently under antibiotic treatment or have received antibiotic treatment within the past 30 days\n- Patients currently pregnant or breastfeeding\n- Patients with ASA IV classification (American Society of Anesthesiologists physical status classification)\n- Patients with severe pulmonary disease\n- Patients with autoimmune thrombocytopenia\n- Patients with severe renal impairment (eGFR < 40 ml/min)\n- Patients with alcohol use disorder or history of drug abuse\n- Patients currently in treatment for any malignant or hematological disease\n- Patients with a previous history of cancer will be excluded from the study (except for patients with well-treated and stabile cancer after a control period of more than two years).\n- Patients with anticipated compliance problems as determined by the investigator"}

Primary endpoints

• {"endpoint_text":"- Change in the pouchitis disease activity index (PDAI","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change in the clinical, endoscopic or histological PDAI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in median WBC, CRP, creatinine and liver enzymes from before application of the study drug to 7 days after application of the study drug","definition_or_measurement_approach":"Laboratory change from baseline to 7 days after application (median WBC, CRP, creatinine, liver enzymes)."}
• {"endpoint_text":"- Change in microbial diversity in the pouch using 16S rRNA sequencing from before application of the study drug to 7 days after application of the study drug","definition_or_measurement_approach":"16S rRNA sequencing comparison of microbial diversity pre-application vs 7 days post-application."}
• {"endpoint_text":"- Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch","definition_or_measurement_approach":"Safety monitoring for serious adverse reactions and adverse reactions following application."}
• {"endpoint_text":"- Assess the modulation of dendritic cells and inflammatory mechanisms using Nanostring nCounter analysis through mRNA expression and flow cytometry","definition_or_measurement_approach":"Assessment via Nanostring nCounter mRNA expression analysis and flow cytometry of dendritic cells and inflammatory markers."}

Denmark

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

58

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

• Reponex Pharmaceuticals A/S